Candel Therapeutics (NASDAQ:CADL) said it remains on track to file a biologics license application in the fourth quarter for aglatimagene, its lead viral immunotherapy candidate, in newly diagnosed localized prostate cancer, according to a company presentation.
The speaker, identified in the transcript as Operator, described Candel as focused on viral immunotherapies for difficult-to-treat solid tumors. The company’s lead asset, aglatimagene, formerly known as CAN-2409, is designed as an off-the-shelf prodrug-based therapy that aims to trigger an individualized anti-tumor immune response specific to a patient’s tumor.
Prostate Cancer Program Shows Disease-Free Survival Benefit
The presentation focused primarily on newly diagnosed localized prostate cancer in patients with intermediate-risk disease or high-risk disease with a single high-risk factor who elect radiotherapy with curative intent. The speaker said the company is targeting roughly 65,000 patients annually in the U.S. who choose radiotherapy and face a recurrence risk of about 30%.
In the phase 3 study, 745 patients received external beam radiotherapy and were randomized 2-to-1 to receive either three administrations of aglatimagene injected into the prostate or placebo. All patients also received valacyclovir, a generic antiviral used as a prodrug in the treatment regimen. The trial allowed physicians to decide whether patients received short-term androgen deprivation therapy, and about half did.
The speaker said the primary endpoint, disease-free survival, was agreed with the FDA under a Special Protocol Assessment. The company reported a hazard ratio of 0.7 and a P value of 0.055, which the speaker characterized as a 30% reduction in risk or improvement in disease-free survival. For prostate cancer-specific disease-free survival, the company reported a hazard ratio of 0.62, which the speaker said reflected a 38% reduction in prostate cancer-specific events.
Candel also reported that 80% of patients receiving aglatimagene achieved a pathological complete response at two years, compared with 63% of patients in the placebo group. The speaker said the two-year biopsy endpoint is important because prior research links positive biopsies after radiotherapy with higher odds of biochemical failure, metastatic disease and prostate cancer death over longer follow-up periods.
Updated data presented at the American Urological Association meeting showed a median follow-up of 58 months. The speaker said the benefit in prostate cancer-specific disease-free survival remained durable, with a 39% improvement reported after prolonged follow-up. The company also discussed trends in time to salvage anti-cancer therapy, biochemical failure and metastasis. In an intermediate-risk subset of 635 patients, the speaker reported a hazard ratio of 0.1 for time to metastasis, describing it as supportive information.
Safety Profile and Regulatory Timeline
The speaker said aglatimagene was generally well tolerated, with flu-like symptoms occurring in about one-third of patients. Those symptoms were described as typically mild and lasting one or two days. The company said serious adverse events were not increased compared with placebo.
The speaker said additional detail on the prostate cancer results appeared in a paper published in The Lancet Oncology. Candel said it is still on track for a fourth-quarter BLA filing for aglatimagene in newly diagnosed localized prostate cancer.
Non-Small Cell Lung Cancer Phase 3 Trial Planned
Candel also discussed plans to begin a global phase 3 trial in metastatic, progressive, non-squamous non-small cell lung cancer. The speaker said the company is targeting patients whose disease progressed after treatment with KEYTRUDA and cisplatin-based chemotherapy.
The planned study is expected to enroll 500 patients. Patients will be randomized either to continue KEYTRUDA with two administrations of aglatimagene or to stop immune checkpoint inhibitor therapy and receive docetaxel, the standard-of-care comparator described in the presentation. The primary endpoint will be overall survival.
The speaker said earlier data showed a median overall survival of 25.4 months in patients with progressive non-squamous disease at baseline and described a potential “long tail” of survival, noting that some patients lived three, four or nearly five years. The FDA has granted Fast Track designation for aglatimagene in this setting, according to the presentation.
Earlier-Stage Glioblastoma Program Highlighted
Candel also highlighted linoserpaturev, formerly known as CAN-3110, an earlier-stage viral immunotherapy candidate. The speaker described it as a replication-competent herpes simplex virus designed to replicate specifically in tumor tissue while sparing healthy tissue.
The company is evaluating linoserpaturev in recurrent glioblastoma, an area the speaker described as a major unmet need. The speaker said the company has dosed 62 patients and has observed cases of extended survival, including after a single injection. Candel has received Fast Track and Orphan Drug designations for linoserpaturev in recurrent glioblastoma and is planning a randomized controlled phase 2 study.
Cash Runway and Upcoming Milestones
The speaker said Candel has a cash runway into the first quarter of 2028 and potentially into commercialization based on current financing. Upcoming milestones cited in the presentation include initiation of the phase 3 non-small cell lung cancer trial, a new biomarker update in prostate cancer in the third quarter, an update in the fourth quarter on long-term survival after linoserpaturev in recurrent glioblastoma, and the planned fourth-quarter BLA filing for aglatimagene in localized prostate cancer.
About Candel Therapeutics (NASDAQ:CADL)
Candel Therapeutics (NASDAQ:CADL) is a clinical-stage immuno-oncology company focused on the development of next-generation oncolytic viral therapies designed to treat solid tumors. The company’s lead candidate, CAN-2409, is a locally administered, gene-delivered viral therapy engineered to selectively replicate in cancer cells and induce immunogenic cell death. Candel leverages proprietary virus engineering platforms to enhance tumor-specific replication and stimulate anti-tumor immune responses, aiming to improve outcomes for patients with high unmet medical needs.
In addition to its lead program, Candel’s pipeline includes CAN-3110, an oncolytic herpes simplex virus targeting recurrent high-grade glioma, and other novel viral constructs being explored for a variety of solid tumor indications.
